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ON-EPIC Oral nitrate supplementation to enhance pulmonary rehabilitation in chronic obstructive pulmonary disease

ON-EPIC Oral nitrate supplementation to enhance pulmonary rehabilitation in chronic obstructive pulmonary disease: a multi-centre, double blind, placebo-controlled, cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27860457
Enrollment
140
Registered
2014-10-29
Start date
2015-01-26
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease (COPD)

Interventions

Beetroot juice drink or matched nitrate-depleted placebo.

Sponsors

Imperial College, London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients will need to have a clinical and spirometric diagnosis of COPD, GOLD stage II-IV and with an MRC score of 3-5 or to be functionally limited

Exclusion criteria

Exclusion criteria: 1. Clinically unstable patients (within one month of exacerbation) 2. Within one month of completing pulmonary rehabilitation 3. Significant comorbidity limiting exercise tolerance 4. Significant renal impairment (estimated glomerular filtration rate (eGFR) <50 ml.min-1) 5. Hypotension (systolic blood pressure <100 mmHg) 6. Pregnancy 7. Use of nitrate based medication 8. Other reason for benefit from nitrate supplementation (ischaemic heart disease, peripheral arterial disease) 9. Use of long-term oxygen therapy

Design outcomes

Primary

MeasureTime frame
Incremental shuttle walking test (ISWT) distance

Secondary

MeasureTime frame
All outcomes measured at 8 weeks: 1. Health status measured by the COPD assessment test score (CAT) and the Hospital Anxiety and Depression scale (HADs) 2. Fat free mass determined by bioelectrical impedance analysis 3. Flow mediated dilatation (FMD) Removed 16/04/2018: 4. Blood plasma NO2 levels (a marker of NO production and availability) as an exploratory variable

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026